Provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in various countries and collaborate closely with multiple functions within Insmed and with external CROs/CMOs. Interpret regulatory guidance and regulations from various health authorities, as well as industry and government agency best practices and trends.
The Manager, Regulatory CMC is responsible for supporting Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to the development and commercialization of the company’s product. This role works closely with cross-functional teams, including Manufacturing, Quality Assurance, Quality Control, and Research, to compile and maintain high-quality regulatory submissions. The Manager will assist in the preparation of CMC content for INDs/CTAs and amendments, assess change controls for regulatory impact, and help ensure compliance with applicable US and global regulatory requirements.